Observational Evaluation of Atopic Dermatitis in Pediatric Patients
This study is for children aged 0 to 11 who have moderate to severe eczema, also known as atopic dermatitis. This is eczema that hasn't improved enough with standard creams or when those creams aren't suitable. The main goal is to understand more about these children's eczema, how it progresses over time, and if they have any other related conditions like allergies or asthma. Researchers also want to see how current treatments are being used in everyday life – things like dosage, how long they're taken for, and why they might be stopped or changed. It's an 'observational' study, which means doctors will simply watch and record information about the children and their existing treatments, without introducing any new medicines or procedures.
At a glance
What is this study about?
This study is called 'Observational Evaluation of Atopic Dermatitis in Pediatric Patients.' It's all about understanding eczema, specifically in children aged 0 to 11 years whose eczema is moderate to severe. 'Moderate to severe' means it's quite bothersome and hasn't responded well to creams or ointments applied to the skin, or perhaps those topical treatments aren't suitable for them. In this type of situation, doctors might consider stronger treatments that work throughout the body, like medications taken by mouth or injections, or light therapy (phototherapy).
The main aims of this study are to get a clearer picture of what it's like for these children living with eczema. Researchers want to describe their symptoms, how their eczema changes over many years, and if they also have other related conditions like asthma or hay fever, which are sometimes seen alongside eczema. They also want to understand the 'burden' of the disease – meaning how much it affects the child's and family's daily lives – and where current treatments might not be meeting their needs.
Another important part of the study is to see how treatments for eczema are actually used in everyday life. This means looking at how doctors decide on doses, for how long treatments are given, and common reasons why a child might stop a treatment or switch to a different one. The study will also gather information on how well these treatments are working and if they cause any side effects in real-world settings. This is a long study, lasting 10 years, to gather a lot of information over time.
Key takeaways
- This study collects information on children with moderate to severe eczema (atopic dermatitis).
- It helps understand how eczema affects children aged 0-11 and how it changes over time.
- Researchers will observe existing treatments; no new medicines are given.
- The study lasts up to 10 years, using information from regular doctor visits.
- Participation helps future understanding and treatment of childhood eczema.
Who may be eligible?
This study is looking for children aged 0 (newborns) up to 11 years old. Both boys and girls can take part. To be considered, your child needs to have eczema that a doctor would describe as moderate to severe.
Your child should either currently be taking medication that works throughout the body (like tablets or injections for eczema) or undergoing light therapy for their eczema. Alternatively, if your child is currently only using creams but their doctor feels they would benefit from these stronger, 'systemic' treatments, they might also be suitable.
There's one main reason a child wouldn't be able to join: if they are already taking part in another clinical trial that is testing a new treatment or making changes to their regular care. This study is about observing standard care, not testing new things.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is your child between 0 and 11 years old?
- Does your child have moderate to severe eczema?
- Is your child currently using treatments like oral medication, injections, or light therapy for eczema?
- Or, is your child using creams, but their doctor thinks they might need stronger treatments?
- Is your child NOT currently in another study that tests new treatments?
What does participation involve?
If your child participates in this long-term study, it means that information about their eczema and their treatment will be collected by their doctor over a period of up to 10 years. This is not a study where new medications are given or new tests are performed. Your child will continue to receive their usual care for eczema as decided by their doctor. The research team will simply gather information from your child's medical records and possibly through regular check-ups or questionnaires during their routine doctor visits.
There won't be any extra visits solely for this study. All information will be collected during your child's existing appointments. The doctors will record details about your child's eczema symptoms, how severe it is, the treatments they are receiving (like creams, oral medications, or light therapy), how long they use these treatments, and any changes made. They will also note any other related conditions your child might have, like asthma. You and your child will be followed for a full 10 years to see how the eczema progresses over a long period.
Potential risks and benefits
Locations (182)
- C Squared Research Center- Site Number : 8400068Verified postcodeBirmingham, United States
- Cahaba Dermatology & Skin Health Center- Site Number : 8400046Verified postcodeBirmingham, United States
- C2 Research Center, LLC- Site Number : 8400071Verified postcodeMontgomery, United States
- Phoenix Children's Hospital, Inc.- Site Number : 8400015Verified postcodePhoenix, United States
- Orange County Research Institute- Site Number : 8400028Verified postcodeAnaheim, United States
- Axis Clinical Trials- Site Number : 8400025Verified postcodeLos Angeles, United States
- Madera Family Medical Group- Site Number : 8400054Verified postcodeMadera, United States
- Carey Chronis, MD, FAAP- Site Number : 8400033Verified postcodeVentura, United States
- Daxia Trials- Site Number : 8400082Verified postcodeBoca Raton, United States
- Frieder Dermatology- Site Number : 8400085Verified postcodeBoca Raton, United States
- Pediatric Center of Excellence (PCE) - Miami Pediatric Endocrinology, LLC- Site Number : 8400072Verified postcodeCoral Gables, United States
- Green Dermatology and Cosmetic Center. Site Number : 8400078Verified postcodeDeerfield Beach, United States
Common questions
What is 'atopic dermatitis'?
Atopic dermatitis is the medical term for eczema, a common skin condition that causes dry, itchy, inflamed patches on the skin.
Will my child receive new medicine in this study?
No, this study only observes the treatments your child is already receiving as part of their normal care. No new medicines are being tested.
How long does the study last for each child?
Each child's information will be collected over a period of up to 10 years.
Do we have to make extra hospital visits for this study?
No, all information will be collected during your child's routine doctor or hospital appointments for their eczema. There are no extra visits.
What does 'observational' mean?
It means doctors will simply watch and record information about your child's eczema and current treatments, without changing anything about their care or giving them new treatments.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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